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M. Tsuboi
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P1.05 - Poster Session with Presenters Present (ID 457)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Early Stage NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.05-051 - Safety and Compliance Data of the Phase III Study of Adjuvant Chemotherapy in Completely Resected P-Stage I Non Small Cell Lung Cancer: JCOG0707 (ID 3877)
14:30 - 14:30 | Author(s): M. Tsuboi
- Abstract
Background:
Post-operative UFT (tegafur/uracil) has been shown to prolong survival of Japanese patients (pts) with completely resected, pathological (p-) stage I (T1> 2 cm) non small cell lung cancer (NSCLC). This trial aimed at estimating the efficacy of S-1 (tegafur/gimeracil/oteracil) compared to UFT as adjuvant therapy in this population.
Methods:
Eligible pts had undergone complete resection with lymph node dissection for p-stage I (T1-2N0M0, T1> 2 cm, by 5[th] Edition UICC TNM) NSCLC, within 56 days of enrollment. Pts were randomized to receive either oral UFT 250mg/M2/d for 2 years (Arm A), or oral S-1 80mg/M2/d for 2 weeks followed by 1 week of rest, for 1 year (Arm B). The initial primary endpoint was overall survival (OS). Based upon the results of monitoring in Jun. 2013, which showed the combined OS of the 2 arms better than expected (4-year OS of 91.6% vs. presumed 5-year OS of 70-76.5%), the study was judged to be underpowered. The study protocol was amended so that the primary endpoint was relapse-free survival (RFS). With a calculated sample size of 960, this study would detect the superiority of Arm B over Arm A with power 79% and a one-sided type I error of 0.05, assuming the 5-year RFS of 75% in Arm A and the hazard ratio of 0.75.
Results:
From Nov. 2008 to Dec. 2013, 963 pts were enrolled: median age 66 (range: 33 to 80), male 58%, adenocarcinoma 80%, p-T1/T2 46%/54%. Only 2 pts received pneumonectomy. All pts had completed protocol therapy. >Grade 3 toxicities (hematologic/nonhematologic) were observed in 15.9 (1.5/14.7) % in Arm A, and in 14.6 (3.6/11.9) % in Arm B, respectively. In Arm A, 59.5% of the pts completed protocol therapy, and 70.7% received UFT for >1 year, which was comparable to prior studies. In Arm B, 54.7% completed protocol therapy, and 69.9% received S-1 for > 6 months. There were 4 cases of on-protocol deaths, probably of cardio-vascular origin: 1 in Arm A and 3 in Arm B. Based on the 2[nd] interim analysis in Sep. 2015, the data and safety monitoring committee recommended the follow-up of pts without unmasking of treatment arms. Estimated combined 2-year OS and RFS were 97.3% and 89.6%, respectively.
Conclusion:
Both post-operative adjuvant therapies were feasible, with similar compliances. Main results will be available in 2019.
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P1.05-052 - An Exploratory Analysis of Postoperative Adjuvant Chemotherapy with Tegafur-Uracil on Survival for Lung Adenocarcinoma (ID 4551)
14:30 - 14:30 | Author(s): M. Tsuboi
- Abstract
Background:
The Eighth Edition of the TNM Classification (TNM 8[th]) for non-small cell lung cancer (NSCLC) proposes a more detailed classification of primary tumor diameter (T). Tegafur-uracil (UFT) improves survival in patients with stage I adenocarcinoma of the lung based on the results of Japan Lung Cancer Research Group (JLCRG: Kato H, et al. N Engl J Med. 2004). However, it is controversial whether the effect of UFT on survival in each T category be the same when TNM[8th] is adopted.
Methods:
This exploratory analysis was performed on the subgroup of 979 eligible patients in JLCRG study. The hazard ratio and the 95% confidence interval (CI) for overall survival in each T category of TNM 8[th] were estimated using stratified Cox proportional hazards models, stratified by sex and age. The overall survival in each T category was estimated by the Kaplan-Meier method.
Results:
The UFT group and the observation group were reanalyzed based on the new classifications of T category defined by TNM[8th], T1a (T, ≤1 cm), T1b (T, >1 to ≤2 cm), T1c (T, >2 to ≤3 cm), T2a (T, >3 to ≤4 cm), T2b (T, >4 to ≤5 cm), and T3 (T, >5 to ≤7 cm). The major prognostic factors did not differ significantly between these two groups in each T category. The benefits of UFT on overall survival varied in each T category (Table 1). Figure 1
Conclusion:
UFT tended to improve survival in each T category defined by TNM[8th], except for T1b, when compared to surgery alone.
